This study has been transitioned to CTIS with ID 2023-503793-20-00 check the CTIS register for the current data. The main purpose of this study is to learn whether asundexian works better than placebo at reducing ischemic strokes in participants who…
ID
Source
Brief title
Condition
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- ischemic stroke.
- ISTH major bleeding.
Secondary outcome
- All strokes (ischemic and hemorrhagic)
- Composite of CV death, MI or stroke
- Composite of all-cause mortality, MI or stroke
- Disabling stroke (mRS >=3 at 90 days)
- All-cause mortality
- Transient ischemic attack (TIA)
- Composite of ISTH major or clinically relevant non-major bleeding
- ISTH clinically relevant non-major bleeding
- Symptomatic intracranial hemorrhage
- Hemorrhagic stroke
- Fatal bleeding
- Minor bleeding
- Composite of ischemic stroke or ISTH major bleeding
- Composite of CV death, all stroke, MI or ISTH major bleeding
- Composite of all-cause mortality, disabling stroke, fatal bleeding,
symptomatic intracranial hemorrhage
Background summary
Researchers are looking for a better way to prevent an ischemic stroke. People
who already had a non-cardioembolic stroke are more likely to have another
stroke. This is why they are treated preventively with an antiplatelet therapy,
the current standard of care. Anticoagulants are another type of medicine that
prevents blood clots. The study treatment asundexian is a new type of
anticoagulant currently under development to provide further treatment options.
Study objective
This study has been transitioned to CTIS with ID 2023-503793-20-00 check the CTIS register for the current data.
The main purpose of this study is to learn whether asundexian works better than
placebo at reducing ischemic strokes in participants who recently had a
non-cardioembolic ischemic stroke or high-risk TIA when given in addition to
standard antiplatelet therapy. Another aim is to compare the occurrence of
major bleeding events during the study between the asundexian and the placebo
group.
Study design
A multicenter, international, randomized, placebo controlled, double-blind,
parallel group, event driven phase 3 study.
Intervention
- asundexian (once daily, oral)
- placebo (once daily, oral)
Study burden and risks
Dependent on the treatment group, the participants will either take asundexian
or placebo for at least 3 months up to 31 months. Approximately every 3 months
during the treatment period, either a phone call or a visit to the study site
is scheduled on an alternating basis. During the study, the following
procedures will be done: vital signs check such as blood pressure and heart
rate, ECG, blood sampling and the participants will be asked to complete a
questionnaire on quality of life.
Siriusdreef 36
Hoofddorp 2132WT
NL
Siriusdreef 36
Hoofddorp 2132WT
NL
Listed location countries
Age
Inclusion criteria
1. Participants must be >= 18 years of age
2. Acute non-cardioembolic stroke or high-risk TIA
3. Systemic or cerebrovascular atherosclerosis or acute non-lacunar infarct
Exclusion criteria
1. Ischemic stroke <= 7 days before the index stroke event
2. Index stroke following procedures or strokes due to other rare causes
3. History of atrial fibrillation/flutter, left ventricular thrombus, mechanic
valve or other cardioembolic source of stroke requiring anticoagulation
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2023-503793-20-00 |
| EudraCT | EUCTR2022-001067-27-NL |
| CCMO | NL82515.056.22 |